Naming of Drug Molecules and Pharmaceutical Brands
Dr. Amit Gangwal,
Smriti College of Pharmaceutical Education,
For running any business or organization their products or services should be of utmost quality keeping other things aside. These products or services are known in commerce by their names. These names are called brand names and these are assigned by the owner or innovator or researcher or sponsor of that product or service depending on the type of produce and various parameters. Though company introduces the brand in commerce but after its (brand’s) establishment, brand becomes the identity of company. Brand names are most important attribute of a product after its quality and packing from end user’s (customer) point of view. Successful brand names never escape from the memory of consumer. Few such brand names are Bislery, Maggi, Vicks, Surf Excel, Coca-Cola, Google etc. Few reputed and well known pharmaceutical brands are Corex, Lipitor, Gleevac, Viagra etc. In present article various process to name a drug and a pharmaceutical formulations’ name (brand name) have been described. Article throws light on generic, chemical and brand names of a drug or formulations besides few case studies and guidelines.
Reference ID: PHARMATUTOR-ART-1243
IMPORTANT IN THIS ARTICLE:
A brand is a name, term, design symbol or any other stuff which is viewable and differentiates that stuff from other company’s product or services. A brand is a trust imposed by its users in that product or service. This faith in the brand is accumulated over the years while using the same product again and again by the end user. A brand helps the consumers to identify and purchase a brand because of its quality and ability to satisfy the customers in a desired way. This basic principle also applies to pharmaceutical brands. In this case the customers are the patients who resort to medicines recommended by physicians. By registering a brand, the owner of the pharmaceutical brand protects the goodwill of the business. The registered owner of a pharmaceutical brand receives the right to use the registered brand. The owner can stop other traders from using his brand without his consent. The potential return on investment from choosing an appropriate brand name should compel any entrepreneur to devote time and effort to getting it right. A persuading and powerful brand name delivers immediate, direct benefits in terms of sales and consumer loyalty, as well as indirect competitive advantages when raising capital or offering shares of stock to the public. Another major reason for taking the necessary steps to select the best available trademark is to protect the owner's already sizable investment of time, money, and resources in developing the drug. Safety has become a major element in the naming of a new proprietary drug because consumer confusion over drug’s brand names can have deadly consequences1. A pharmaceutical brand is different from other brands in the sense that the former has a generic name too besides a name given by proprietor of that product. If the company launches a new drug molecule in market with a convincing, impressive and everlasting (doctor and patient friendly) name and sound then it will persists in the memory of not only customers (patients) but also healthy ones. The name should be recalled in no time. Once the brand is established as the leading one in its therapeutic segment then all the subsequent names falling in that category will probably live in the shadow of this original brand. Names worth mentioning here are Xerox, Bislery, Pepsi, Lux, Corex, Steptsils, Eno etc.Here quality is of paramount importance because if innovator products like Xerox, Maggi, Bislery etc would not have been effective and quality-filled then people would not have demanded even other brands with these brand names. In present paper, an attempt has been made to describe in details about generic and brand names of a drug and a formulation respectively. Various rationales and cases have been mentioned to make paper lucid and comprehensive.
Names of a drug
A marketed drug has three names: a chemical name, a generic name, and a brand name.
Chemical name: A chemical name is decided on the basis of chemical structure of drug and is used primarily by researchers. A drug's chemical name is long and usually difficult to pronounce and remember; consumers, physicians, and pharmacists are therefore better served by referring to the drug's generic name. The chemical name is generally not used in practice, unless it becomes the established or used name such as sodium chloride. Chemical names are not given in any of the standard manuals, such as the Physicians' Desk Reference, official books like United States Pharmacopeia (USP), or available software.
Generic name: Drug’s official name is generic name throughout its lifetime world over regardless of who made it, how it was made, where it was devised. Generic name is commonly used by health care professionals and is usually created when a new drug is ready to be marketed. Although the manufacturer or sponsor of the drug has the exclusive right of manufacture during the 17 years of the drug's patent, it never owns the generic name. The manufacturer or sponsor of the drug usually initiates the request for a generic name, but the generic name is always in the public domain and there is no need of using such letters as TM or ® or © with generic names. Once the drug's patent expires, other manufacturers may make the drug, referring to it by its generic name. In the United States, the generic name must first be approved by the U.S. adopted name (USAN) council. The USAN council is responsible for creating and assigning a functional generic name to the drug. Before being approved by the council, the generic name must be screened to ensure that it does not look or sound too similar to any other generic or brand name and must also be considered appropriate for the specific drug. After approving the generic name, the council submits the name to WHO, which has final approval. The name is published in the trademark bulletin of the pharmaceutical research and manufacturers of America to allow comments or protests. If no such comments are objections are received then the name is considered final. After being approved by WHO, the drug is assigned an international nonproprietary name i. e. generic name. The USAN council adheres to a list of established guidelines in name selection. The most important criterion considered when issuing a generic name is the usefulness of that name to health care providers. The name should be short, easy to pronounce, and euphonic. The name cannot be misleading or confusing; prefixes implying a general descriptive adjective, such as new or improved, would not be accepted, nor would prefixes suggesting the manufacturer's name or an anatomical designation. A stem (a word common to members of a related group of drugs based on their use) is included so that shared characteristics (such as pharmacologic action) can be identified. For example, anti-inflammatory drugs commonly have an “fen” stem (ibuprofen, acetaminophen, diclofenac). The council uses many other specific guidelines; such guidelines include rules for preferred spelling, use of isolated letters and numbers and hyphenation, and rules for drugs that contain radioactive atoms. Federal law makes it compulsory to use generic names in advertising and on labels and brochures. The generic name is essential to pharmacists and other health care professionals, primarily because of the stem. Because of the USAN council's systematic approach to developing a generic name, pharmacists “can often tell you the chemical composition of it and what its indications and adverse reactions are. If a drug ends with “pril” they know it belongs to the class called ACE (angiotensin-converting enzyme) inhibitors.
Brand Name: Although the generic name is in the public domain, the brand name (the legal term for brand is trademark) is owned solely by the manufacturer and can be created as soon as the generic name has been approved. Unlike generic names, which are created by the manufacturer in conjunction with the USAN council, choice of the brand name is motivated by marketing considerations and solely rests with the innovator/organization of that molecule. Brand name is chosen by the company that wants to market the product and it is a marketing decision, however, the FDA must approve the name. Although the USAN council is actively involved in name selection, the FDA has authority over drug labeling and is essentially responsible for approving or disapproving the brand name of the drug. If the USAN council receives a submission for a name it considers inappropriate, the council will suggest another name; but if the FDA disapproves of the name, the manufacturer must propose a new brand name. The FDA tries to avoid excessive similarity between brand and generic names. Creating a generic name is a science and it does not influence the sell of that brand but creating a brand name is more of an art and it absolutely alters the selling of the brand. Here it should be noted that if quality product is not produced then brand names prove futile. USAN council has exact guidelines for assigning generic names, but the guidelines for assigning brand names outline what a company should not do while designing a brand name. As long as drug companies adhere to these guidelines, they are essentially free to choose any name for their products.
In October 1999, the FDA transferred the evaluation of proposed new drug names to the newly formed Office of Post-Marketing Drug Risk Assessment (OPDRA), which was part of the Center for Drug Evaluation and Research. At OPDRA, the intensity of the evaluation was augmented. The ultimate goal was the same; to avoid names prone to medication mistakes. In January 2002, the FDA, as part of a reorganization of its risk management function, created the Office of Drug Safety (ODS) and transferred the responsibility for proprietary name reviews and analyzing medication errors data to a division within this new office named Medication Errors and Technical Support (METS). The proprietary name review begins when the owner of the new drug submits its proposed proprietary name(s) to the appropriate medical review division, which forwards it to METS for risk assessment. This may be as early as the end of Phase II of clinical development (testing of drug candidate in patients before launching in commerce). METS will evaluate no more than two names in its review. The names must be listed in order of preference and, if the first candidate is approved, no evaluation will be done for the second name. The standard of analysis is whether the proposed new drug name sounds or looks confusingly similar to another generic or branded drug. Drug names that sound alike can lead to errors in verbal medication orders and drug brands that look the same can be confused when written in prescriptions and dispensing orders. A safety evaluator in METS examines the overall safety risk of the new name. This name review includes a comparison of the new name against all existing proprietary and generic drug names marketed in the United States. The fact that the proposed new drug name may have been "allowed" by the Trademark Office or registered as a trademark is not considered in the evaluation process. ODS and its METS division are concerned only with the assessment of risk created by the drug name as used in a clinical context. The empirical testing part of the evaluation includes handwriting analysis in which test prescriptions and medication orders incorporating the proposed drug name are created and evaluated at both the hospital and pharmacy level. Verbal analysis is also conducted in simulated clinical environments to assess potential communication errors with other sound-alike drugs. The results of these studies are evaluated by a panel of ODS experts, and a written evaluation is forwarded to the Medical Review Division for that drug. A drug name that is tentatively approved must also undergo a second review 90 days prior to the approval of the drug itself. This second evaluation is limited to a comparison of any potentially confusing proprietary and generic drug names that have been approved after the initial evaluation of the new drug name. A crucial element in this dual regulatory approval process is timing. It does no good to obtain a FDA-approved drug name if another party owns a trademark registration for the same or similar mark that conveys the exclusive right to use the mark with a pharmaceutical product in the United States. On the other hand, a trademark registration for a pharmaceutical product is useless without FDA approval of that proprietary brand name. To avoid such a potential stand-off, pharmaceutical and life science companies must carefully consider the anticipated time table for clinical testing and FDA drug approval. It is always advisable to conduct trademark clearance searches of several alternative names for a new drug before selecting the name or names to be submitted to the FDA. Trademark applications for the final candidates should also be filed before the names are submitted to FDA to lock up trademark rights to the selected proprietary drug names. The trademark owner then has 3 years to establish use of the mark in commerce and obtain the registration. This gives the drug maker legal priority over the trademark drug name for 4 years or more while it pursues FDA approval of the drug and its proprietary brand name2.
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